Job Description

Lead the development of clinical research plans, integration of the Clinical Development Plan (CDP) and Drug Development Plan, and development of Clinical Protocols.

Drive the execution of clinical study from protocol concept to final resport, including the intepretation of clinical data.

Act as the Medical Monitor for a study/clinical program, review and monitor study safety data.

Serve as clinical/medical team expert to provide direction to all project team functions, organize Advisory Board meetings, and identify and liase with KOL regarding program strategy as well as scientific advice.

Interpret study data and develop summaries for safety and efficacy.

Reviews 3rd party (contractors, consultants and vendors) work product and deliverables to approve payment of invoices and resolves issues.